FDA Approves Home-Use Device for Depression Treatment

Depression rates have significantly increased in the U.S., prompting the FDA to approve a new home-use device for treatment. Flow's FL-100 delivers a gentle electrical current to the brain's mood-regulating regions, offering a prescription-only option for adults aged 18 and older suffering from moderate to severe major depressive disorders. This innovative device can be used as a standalone treatment or alongside existing therapies.

The device is slated for a U.S. launch in the second quarter of 2026, with Flow's CEO targeting a retail price between $500 and $800. The company is actively negotiating insurance coverage partnerships, with announcements expected in early 2026. Globally, the FL-100 has already been utilized by over 55,000 individuals, with many reporting symptom improvement within weeks.

Clinical studies indicate that a substantial percentage of patients achieved remission after a 10-week treatment course. The typical treatment involves a 12-week regimen with daily sessions initially, tapering off over time. While generally mild, potential side effects include skin irritation and headaches, with rare instances of burns reported if device pads are reused or dried.